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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076960
Company: HIKMA

Products on ANDA 076960

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076960

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/2006	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/23/2022	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
06/23/2022	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/14/2018	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
05/14/2018	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/02/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/17/2012	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
10/13/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/30/2010	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076960

ONDANSETRON HYDROCHLORIDE

SOLUTION;ORAL; EQ 4MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	091483	AMNEAL PHARMS
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	078776	AUROBINDO PHARMA
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	091342	CHARTWELL MOLECULAR
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	076960	HIKMA
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	077009	TARO

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